Essential Hypertension
Conditions
Keywords
Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor
Brief summary
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.
Interventions
DRUGOlmesartan
10 mg, 20 mg, 40 mg capsules
DRUGPlacebo
Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
DRUGLCZ696
100 mg, 200 mg tablets
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must give written informed consent before any assessment is performed * Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and \< 180 mmHg * Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance
Exclusion criteria
* Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise * Patients with history or evidence of a secondary form of hypertension * Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke * History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. * Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates). * Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication * Patients with previous or current diagnosis of heart failure (NYHA Class II-IV). * Patients with a clinically significant valvular heart disease at the time of screening * Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline, 10 weeks | Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, 4 weeks, 14 weeks | Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement. |
| Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) | Baseline, 10 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement. |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, 10 weeks | Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement. |
| Change From Baseline in Mean Sitting Pulse Pressure | Baseline, 4 weeks, 10 weeks, 14 weeks | Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit. |
| Change From Baseline in Daytime and Nighttime maSBP/maDBP | Baseline, 10 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement. |
| Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) | Baseline, 10 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement. |
| Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | Baseline, 10 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement. |
| Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | 4 weeks, 10 weeks, 14 weeks | A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg. |
| Number of Participants Achieving Successful Response in msSBP and msDBP | 4 weeks,10 weeks, 14 weeks | Blood pressure response in msSBP was defined as a mean sitting BP \< 140 mmHg or a \>=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or \>=10 mmHg reduction from baseline. |
| Number of Participants With Adverse Events, Serious Adverse Events and Death | 14 weeks | Adverse event monitoring was conducted throughout the study. |
| Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | Baseline, 10 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement. |
Countries
China, Hong Kong, Japan, Philippines, South Korea, Taiwan, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LCZ696 Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd. | 296 |
| Olmesartan Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd. | 292 |
| Total | 588 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 5 |
| Overall Study | Lack of Efficacy | 1 | 6 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 5 | 1 |
| Overall Study | Protocol deviation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | LCZ696 | Olmesartan | Total |
|---|---|---|---|
| Age, Continuous | 70.5 Years STANDARD_DEVIATION 4.67 | 70.9 Years STANDARD_DEVIATION 4.67 | 70.7 Years STANDARD_DEVIATION 4.67 |
| Sex: Female, Male Female | 154 Participants | 140 Participants | 294 Participants |
| Sex: Female, Male Male | 142 Participants | 152 Participants | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / 296 | 44 / 292 |
| serious Total, serious adverse events | 7 / 296 | 2 / 292 |
Outcome results
Primary
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Population: Only participants, who had both baseline and week 10 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LCZ696 | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -22.71 mmHg | Standard Error 0.91 |
| Olmesartan | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | -16.11 mmHg | Standard Error 0.92 |
Secondary
Change From Baseline in Daytime and Nighttime maSBP/maDBP
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Population: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LCZ696 | Change From Baseline in Daytime and Nighttime maSBP/maDBP | maDBP, daytime | -7.04 mmHg | Standard Error 0.55 |
| LCZ696 | Change From Baseline in Daytime and Nighttime maSBP/maDBP | maSBP, daytime | -14.32 mmHg | Standard Error 0.96 |
| LCZ696 | Change From Baseline in Daytime and Nighttime maSBP/maDBP | maDBP, nighttime | -6.70 mmHg | Standard Error 0.55 |
| LCZ696 | Change From Baseline in Daytime and Nighttime maSBP/maDBP | maSBP, nighttime | -13.97 mmHg | Standard Error 0.96 |
| Olmesartan | Change From Baseline in Daytime and Nighttime maSBP/maDBP | maDBP, nighttime | -3.61 mmHg | Standard Error 0.56 |
| Olmesartan | Change From Baseline in Daytime and Nighttime maSBP/maDBP | maSBP, daytime | -10.02 mmHg | Standard Error 0.96 |
| Olmesartan | Change From Baseline in Daytime and Nighttime maSBP/maDBP | maDBP, daytime | -4.88 mmHg | Standard Error 0.56 |
| Olmesartan | Change From Baseline in Daytime and Nighttime maSBP/maDBP | maSBP, nighttime | -7.68 mmHg | Standard Error 0.96 |
Secondary
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Population: A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 5 (n=61,67) | -16.70 mmHg | Standard Deviation 17.689 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 18 (n=61,68) | -11.19 mmHg | Standard Deviation 16.482 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 17 (n=62,68) | -5.71 mmHg | Standard Deviation 12.089 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 19 (n=62,68) | -12.38 mmHg | Standard Deviation 15.01 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 6 (n=62,68) | -18.11 mmHg | Standard Deviation 17.856 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 20 (n=62,68) | -15.18 mmHg | Standard Deviation 16.683 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 16 (n=62,68) | -9.90 mmHg | Standard Deviation 17.994 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 21 (n=62,67) | -13.71 mmHg | Standard Deviation 19.977 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 7 (n=62,68) | -17.60 mmHg | Standard Deviation 18.33 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 22 (n=62,68) | -19.28 mmHg | Standard Deviation 19.387 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 18 (n=61,68) | -5.36 mmHg | Standard Deviation 11.213 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 23 (n=60,66) | -16.88 mmHg | Standard Deviation 15.442 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 8 (n=62,67) | -15.81 mmHg | Standard Deviation 15.872 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 4 (n=62,68) | -7.35 mmHg | Standard Deviation 10.656 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 2 (n=62,66) | -9.13 mmHg | Standard Deviation 9.854 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 9 (n=62,68) | -14.06 mmHg | Standard Deviation 12.877 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 3 (n=62,68) | -8.41 mmHg | Standard Deviation 11.698 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 5 (n=61,67) | -8.17 mmHg | Standard Deviation 10.919 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 19 (n=62,68) | -6.10 mmHg | Standard Deviation 11.197 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 6 (n=62,68) | -8.39 mmHg | Standard Deviation 10.623 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 10 (n=62,68) | -15.55 mmHg | Standard Deviation 15.232 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 7 (n=62,68) | -9.14 mmHg | Standard Deviation 11.35 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 9 (n=62,68) | -7.01 mmHg | Standard Deviation 9.374 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 24 (n=57,67) | -17.28 mmHg | Standard Deviation 13.472 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 10 (n=62,68) | -7.83 mmHg | Standard Deviation 9.907 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 11 (n=62,68) | -13.17 mmHg | Standard Deviation 17.903 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 11 (n=62,68) | -8.08 mmHg | Standard Deviation 10.588 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 1 (n=58,66) | -18.48 mmHg | Standard Deviation 14.55 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 12 (n=62,68) | -7.38 mmHg | Standard Deviation 11.993 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 12 (n=62,68) | -12.36 mmHg | Standard Deviation 17.222 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 13 (n=-62,68) | -4.36 mmHg | Standard Deviation 11.325 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 4 (n=62,68) | -16.90 mmHg | Standard Deviation 16.539 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 14 (n=62,68) | -2.70 mmHg | Standard Deviation 13.661 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 13 (n=62,68) | -8.71 mmHg | Standard Deviation 19.359 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 15 (n=62,67) | -4.02 mmHg | Standard Deviation 12.943 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 2 (n=62,66) | -20.75 mmHg | Standard Deviation 15.713 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 16 (n=62,68) | -4.84 mmHg | Standard Deviation 13.097 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 14 (n=62,68) | -7.10 mmHg | Standard Deviation 20.651 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 20 (n=62,68) | -6.75 mmHg | Standard Deviation 10.878 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 8 (n=62,67) | -7.50 mmHg | Standard Deviation 9.68 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 21 (n=62,67) | -6.91 mmHg | Standard Deviation 12.251 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 15 (n=62,67) | -9.05 mmHg | Standard Deviation 18.528 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 22 (n=62,68) | -10.22 mmHg | Standard Deviation 11.394 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 3 (n=62,68) | -17.44 mmHg | Standard Deviation 18.884 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 23 (n=60,66) | -7.85 mmHg | Standard Deviation 9.03 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 1 (n=58,66) | -8.34 mmHg | Standard Deviation 9.64 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 24 (n=57,67) | -7.83 mmHg | Standard Deviation 10.057 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 17 (n=62,68) | -9.88 mmHg | Standard Deviation 16.098 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 24 (n=57,67) | -6.62 mmHg | Standard Deviation 10.418 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 24 (n=57,67) | -16.03 mmHg | Standard Deviation 19.076 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 3 (n=62,68) | -8.21 mmHg | Standard Deviation 9.857 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 4 (n=62,68) | -8.98 mmHg | Standard Deviation 9.835 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 7 (n=62,68) | -7.35 mmHg | Standard Deviation 12.345 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 8 (n=62,67) | -8.50 mmHg | Standard Deviation 10.839 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 17 (n=62,68) | -3.74 mmHg | Standard Deviation 11.261 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 18 (n=61,68) | -1.65 mmHg | Standard Deviation 8.939 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 19 (n=62,68) | -3.42 mmHg | Standard Deviation 9.726 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 1 (n=58,66) | -14.15 mmHg | Standard Deviation 15.677 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 2 (n=62,66) | -17.26 mmHg | Standard Deviation 16.843 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 4 (n=62,68) | -14.83 mmHg | Standard Deviation 17.823 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 5 (n=61,67) | -16.16 mmHg | Standard Deviation 19.46 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 6 (n=62,68) | -15.00 mmHg | Standard Deviation 19.025 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 7 (n=62,68) | -14.74 mmHg | Standard Deviation 20.142 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 8 (n=62,67) | -16.37 mmHg | Standard Deviation 17.552 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 9 (n=62,68) | -13.55 mmHg | Standard Deviation 19.456 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 10 (n=62,68) | -13.50 mmHg | Standard Deviation 17.522 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 11 (n=62,68) | -13.32 mmHg | Standard Deviation 18.198 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 12 (n=62,68) | -13.43 mmHg | Standard Deviation 20.898 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 13 (n=62,68) | -10.84 mmHg | Standard Deviation 19.697 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 14 (n=62,68) | -9.96 mmHg | Standard Deviation 19.663 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 15 (n=62,67) | -8.68 mmHg | Standard Deviation 17.094 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 16 (n=62,68) | -7.81 mmHg | Standard Deviation 16.344 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 17 (n=62,68) | -5.49 mmHg | Standard Deviation 15.031 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 18 (n=61,68) | -4.88 mmHg | Standard Deviation 13.065 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 19 (n=62,68) | -6.69 mmHg | Standard Deviation 15.146 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 20 (n=62,68) | -9.40 mmHg | Standard Deviation 18.217 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 21 (n=62,67) | -9.04 mmHg | Standard Deviation 15.748 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 22 (n=62,68) | -9.61 mmHg | Standard Deviation 18.94 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 23 (n=60,66) | -10.54 mmHg | Standard Deviation 19.47 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 1 (n=58,66) | -7.30 mmHg | Standard Deviation 8.732 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 2 (n=62,66) | -7.80 mmHg | Standard Deviation 10.747 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 5 (n=61,67) | -8.35 mmHg | Standard Deviation 10.282 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 6 (n=62,68) | -8.09 mmHg | Standard Deviation 12.36 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 9 (n=62,68) | -6.65 mmHg | Standard Deviation 12.287 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 10 (n=62,68) | -6.70 mmHg | Standard Deviation 11.536 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 11 (n=62,68) | -6.65 mmHg | Standard Deviation 11.023 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 12 (n=62,68) | -7.64 mmHg | Standard Deviation 13.479 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 13 (n=-62,68) | -7.16 mmHg | Standard Deviation 12.916 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 14 (n=62,68) | -6.28 mmHg | Standard Deviation 10.794 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 15 (n=62,67) | -3.05 mmHg | Standard Deviation 11.417 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 16 (n=62,68) | -3.88 mmHg | Standard Deviation 10.015 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 20 (n=62,68) | -4.00 mmHg | Standard Deviation 12.452 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 21 (n=62,67) | -4.40 mmHg | Standard Deviation 9.746 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 22 (n=62,68) | -4.48 mmHg | Standard Deviation 11.019 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maDBP, hour 23 (n=60,66) | -5.11 mmHg | Standard Deviation 9.826 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers | maSBP, hour 3 (n=62,68) | -12.65 mmHg | Standard Deviation 18.923 |
Secondary
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Population: A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 3 (n=90,88) | -13.17 mmHg | Standard Deviation 15.69 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 12 (n=92,88) | -13.82 mmHg | Standard Deviation 17.493 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 15 (n=92,89) | -19.33 mmHg | Standard Deviation 19.863 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 20 (n=92,89) | -15.33 mmHg | Standard Deviation 15.556 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 23 (n=92,85) | -10.93 mmHg | Standard Deviation 14.121 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 24 (n=86,85) | -14.19 mmHg | Standard Deviation 15.072 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 2 (n=89,85) | -7.39 mmHg | Standard Deviation 10.516 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 3 (n=90,88) | -6.61 mmHg | Standard Deviation 10.473 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 4 (n=91,88) | -7.08 mmHg | Standard Deviation 9.826 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 15 (n=92,89) | -9.60 mmHg | Standard Deviation 13.266 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 21 (n=91,89) | -7.63 mmHg | Standard Deviation 10.871 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 1 (n=84,84) | -13.42 mmHg | Standard Deviation 16.05 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 2 (n=89,85) | -15.60 mmHg | Standard Deviation 18.144 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 4 (n=91,88) | -13.93 mmHg | Standard Deviation 17.26 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 5 (n=90,88) | -12.90 mmHg | Standard Deviation 19.372 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 6 (n=90,89) | -12.96 mmHg | Standard Deviation 22.547 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 7 (n=91,89) | -12.68 mmHg | Standard Deviation 21.126 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 8 (n=91,88) | -12.65 mmHg | Standard Deviation 18.45 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 9 (n=91,89) | -13.51 mmHg | Standard Deviation 17.381 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 10 (n=92,89) | -12.96 mmHg | Standard Deviation 17.35 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 11 (n=92,89) | -12.69 mmHg | Standard Deviation 18.724 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 13 (n=92,89) | -16.51 mmHg | Standard Deviation 16.485 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 14 (n=92,88) | -19.39 mmHg | Standard Deviation 16.86 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 16 (n=92,89) | -17.95 mmHg | Standard Deviation 18.731 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 17 (n=92,89) | -17.34 mmHg | Standard Deviation 17.015 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 18 (n=92,88) | -16.45 mmHg | Standard Deviation 16.439 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 19 (n=91,89) | -15.81 mmHg | Standard Deviation 16.349 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 21 (n=91,89) | -14.78 mmHg | Standard Deviation 15.79 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 22 (n=91,89) | -13.99 mmHg | Standard Deviation 15.653 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 1 (n=84,84) | -7.01 mmHg | Standard Deviation 9.033 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 5 (n=90,88) | -5.75 mmHg | Standard Deviation 13.156 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 6 (n=90,89) | -7.06 mmHg | Standard Deviation 13.704 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 7 (n=91,89) | -5.69 mmHg | Standard Deviation 12.453 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 8 (n=91,88) | -6.13 mmHg | Standard Deviation 10.42 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 9 (n=91,89) | -7.05 mmHg | Standard Deviation 10.348 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 10 (n=92,89) | -5.28 mmHg | Standard Deviation 10.221 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 11 (n=92,89) | -6.18 mmHg | Standard Deviation 11.825 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 12 (n=92,88) | -6.36 mmHg | Standard Deviation 11.313 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 13 (n=92,89) | -8.63 mmHg | Standard Deviation 11.364 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 14 (n=92,88) | -9.68 mmHg | Standard Deviation 11.518 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 16 (n=92,89) | -8.48 mmHg | Standard Deviation 11.992 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 17 (n=92,89) | -7.60 mmHg | Standard Deviation 9.661 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 18 (n=92,88) | -8.60 mmHg | Standard Deviation 11.526 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 19 (n=91,89) | -7.46 mmHg | Standard Deviation 10.284 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 20 (n=92,89) | -6.21 mmHg | Standard Deviation 10.295 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 22 (n=91,89) | -6.97 mmHg | Standard Deviation 10.589 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 23 (n=92,85) | -5.72 mmHg | Standard Deviation 9.41 |
| LCZ696 | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 24 (n=86,85) | -6.57 mmHg | Standard Deviation 9.916 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 15 (n=92,89) | -5.92 mmHg | Standard Deviation 17.627 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 3 (n=90,88) | -6.33 mmHg | Standard Deviation 17.694 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 11 (n=92,89) | -6.89 mmHg | Standard Deviation 16.115 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 20 (n=92,89) | -3.10 mmHg | Standard Deviation 9.792 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 12 (n=92,88) | -3.92 mmHg | Standard Deviation 17.244 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 16 (n=92,89) | -6.57 mmHg | Standard Deviation 18.512 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 19 (n=91,89) | -9.33 mmHg | Standard Deviation 17.027 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 10 (n=92,89) | -3.14 mmHg | Standard Deviation 10.849 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 20 (n=92,89) | -6.77 mmHg | Standard Deviation 16.228 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 22 (n=91,89) | -6.05 mmHg | Standard Deviation 15.806 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 17 (n=92,89) | -12.03 mmHg | Standard Deviation 18.99 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 23 (n=92,85) | -8.48 mmHg | Standard Deviation 16.76 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 17 (n=92,89) | -5.44 mmHg | Standard Deviation 11.105 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 1 (n=84,84) | -4.59 mmHg | Standard Deviation 10.061 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 18 (n=92,88) | -8.54 mmHg | Standard Deviation 17.397 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 2 (n=89,85) | -3.32 mmHg | Standard Deviation 11.104 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 11 (n=92,89) | -3.18 mmHg | Standard Deviation 10.216 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 3 (n=90,88) | -3.77 mmHg | Standard Deviation 12.284 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 23 (n=92,85) | -2.12 mmHg | Standard Deviation 11.612 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 4 (n=91,88) | -2.24 mmHg | Standard Deviation 11.169 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 14 (n=92,88) | -1.69 mmHg | Standard Deviation 11.103 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 21 (n=91,89) | -7.10 mmHg | Standard Deviation 17.961 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 18 (n=92,88) | -4.25 mmHg | Standard Deviation 11.062 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 12 (n=92,88) | -1.61 mmHg | Standard Deviation 10.97 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 21 (n=91,89) | -2.81 mmHg | Standard Deviation 11.002 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 24 (n=86,85) | -7.98 mmHg | Standard Deviation 16.16 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 1 (n=84,84) | -9.53 mmHg | Standard Deviation 18.224 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 22 (n=91,89) | -2.60 mmHg | Standard Deviation 10.568 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 2 (n=89,85) | -8.57 mmHg | Standard Deviation 17.848 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 13 (n=92,89) | -2.41 mmHg | Standard Deviation 10.75 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 4 (n=91,88) | -4.98 mmHg | Standard Deviation 16.155 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 5 (n=90,88) | -1.53 mmHg | Standard Deviation 12.069 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 5 (n=90,88) | -4.68 mmHg | Standard Deviation 16.264 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 19 (n=91,89) | -3.93 mmHg | Standard Deviation 11.088 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 6 (n=90,89) | -5.49 mmHg | Standard Deviation 18.843 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 6 (n=90,89) | -2.00 mmHg | Standard Deviation 11.418 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 7 (n=91,89) | -6.64 mmHg | Standard Deviation 17.191 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 15 (n=92,89) | -2.85 mmHg | Standard Deviation 11.012 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 8 (n=91,88) | -7.45 mmHg | Standard Deviation 17.912 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 7 (n=91,89) | -1.70 mmHg | Standard Deviation 11.797 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 9 (n=91,89) | -7.81 mmHg | Standard Deviation 16.968 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 24 (n=86,85) | -3.91 mmHg | Standard Deviation 9.24 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 10 (n=92,89) | -7.63 mmHg | Standard Deviation 18.62 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 8 (n=91,88) | -3.04 mmHg | Standard Deviation 11.24 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 16 (n=92,89) | -2.54 mmHg | Standard Deviation 11.523 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 13 (n=92,89) | -5.49 mmHg | Standard Deviation 18.209 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | msDBP, hour 9 (n=91,89) | -3.62 mmHg | Standard Deviation 10.743 |
| Olmesartan | Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers | maSBP, hour 14 (n=92,88) | -5.16 mmHg | Standard Deviation 16.856 |
Secondary
Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Population: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LCZ696 | Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) | -14.23 mmHg | Standard Error 0.56 |
| Olmesartan | Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) | -9.14 mmHg | Standard Error 0.56 |
Secondary
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Population: Participants from the full analysis set (FAS), who had both baseline and week 10 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LCZ696 | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -8.58 mmHg | Standard Error 0.47 |
| Olmesartan | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | -6.49 mmHg | Standard Error 0.48 |
Secondary
Change From Baseline in Mean Sitting Pulse Pressure
Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.
Time frame: Baseline, 4 weeks, 10 weeks, 14 weeks
Population: Participants from the full analysis set (FAS), who had both baseline and post baseline values at the given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LCZ696 | Change From Baseline in Mean Sitting Pulse Pressure | week 4 | -11.57 mmHg | Standard Error 0.6 |
| LCZ696 | Change From Baseline in Mean Sitting Pulse Pressure | week 10 | -14.21 mmHg | Standard Error 0.63 |
| LCZ696 | Change From Baseline in Mean Sitting Pulse Pressure | week 14 | -14.65 mmHg | Standard Error 0.64 |
| Olmesartan | Change From Baseline in Mean Sitting Pulse Pressure | week 4 | -10.38 mmHg | Standard Error 0.61 |
| Olmesartan | Change From Baseline in Mean Sitting Pulse Pressure | week 10 | -9.76 mmHg | Standard Error 0.64 |
| Olmesartan | Change From Baseline in Mean Sitting Pulse Pressure | week 14 | -10.90 mmHg | Standard Error 0.65 |
Secondary
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.
Time frame: Baseline, 4 weeks, 14 weeks
Population: Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LCZ696 | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | msSBP, week 4 | -17.64 mmHg | Standard Error 0.83 |
| LCZ696 | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | msDBP, week 4 | -6.08 mmHg | Standard Error 0.44 |
| LCZ696 | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | msSBP, week 14 | -22.53 mmHg | Standard Error 0.92 |
| LCZ696 | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | msDBP, week 14 | -7.92 mmHg | Standard Error 0.49 |
| Olmesartan | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | msDBP, week 14 | -5.97 mmHg | Standard Error 0.49 |
| Olmesartan | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | msSBP, week 4 | -15.81 mmHg | Standard Error 0.84 |
| Olmesartan | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | msSBP, week 14 | -16.75 mmHg | Standard Error 0.94 |
| Olmesartan | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | msDBP, week 4 | -5.58 mmHg | Standard Error 0.45 |
Secondary
Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.
Time frame: Baseline, 10 weeks
Population: A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LCZ696 | Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) | -6.95 mmHg | Standard Error 0.31 |
| Olmesartan | Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) | -4.47 mmHg | Standard Error 0.31 |
Secondary
Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg.
Time frame: 4 weeks, 10 weeks, 14 weeks
Population: Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCZ696 | Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | 14 weeks | 173 Participants |
| LCZ696 | Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | 4 weeks | 140 Participants |
| LCZ696 | Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | 10 weeks | 175 Participants |
| Olmesartan | Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | 10 weeks | 130 Participants |
| Olmesartan | Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | 14 weeks | 126 Participants |
| Olmesartan | Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) | 4 weeks | 120 Participants |
Secondary
Number of Participants Achieving Successful Response in msSBP and msDBP
Blood pressure response in msSBP was defined as a mean sitting BP \< 140 mmHg or a \>=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or \>=10 mmHg reduction from baseline.
Time frame: 4 weeks,10 weeks, 14 weeks
Population: Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCZ696 | Number of Participants Achieving Successful Response in msSBP and msDBP | msSBP, week 4 | 162 Participants |
| LCZ696 | Number of Participants Achieving Successful Response in msSBP and msDBP | msSBP, week 10 | 208 Participants |
| LCZ696 | Number of Participants Achieving Successful Response in msSBP and msDBP | msSBP, week 14 | 205 Participants |
| LCZ696 | Number of Participants Achieving Successful Response in msSBP and msDBP | msDBP, week 4 | 264 Participants |
| LCZ696 | Number of Participants Achieving Successful Response in msSBP and msDBP | msDBP, week 10 | 275 Participants |
| LCZ696 | Number of Participants Achieving Successful Response in msSBP and msDBP | msDBP, week 14 | 268 Participants |
| Olmesartan | Number of Participants Achieving Successful Response in msSBP and msDBP | msDBP, week 10 | 254 Participants |
| Olmesartan | Number of Participants Achieving Successful Response in msSBP and msDBP | msSBP, week 4 | 146 Participants |
| Olmesartan | Number of Participants Achieving Successful Response in msSBP and msDBP | msDBP, week 4 | 245 Participants |
| Olmesartan | Number of Participants Achieving Successful Response in msSBP and msDBP | msSBP, week 10 | 142 Participants |
| Olmesartan | Number of Participants Achieving Successful Response in msSBP and msDBP | msDBP, week 14 | 246 Participants |
| Olmesartan | Number of Participants Achieving Successful Response in msSBP and msDBP | msSBP, week 14 | 144 Participants |
Secondary
Number of Participants With Adverse Events, Serious Adverse Events and Death
Adverse event monitoring was conducted throughout the study.
Time frame: 14 weeks
Population: Participants from the safety analysis set were analyzed. The safety analysis set included all randomized participants who received study medication and had post baseline assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCZ696 | Number of Participants With Adverse Events, Serious Adverse Events and Death | Serious adverse events | 7 Participants |
| LCZ696 | Number of Participants With Adverse Events, Serious Adverse Events and Death | Adverse events (non-serious and serious) | 141 Participants |
| LCZ696 | Number of Participants With Adverse Events, Serious Adverse Events and Death | Deaths | 0 Participants |
| Olmesartan | Number of Participants With Adverse Events, Serious Adverse Events and Death | Adverse events (non-serious and serious) | 113 Participants |
| Olmesartan | Number of Participants With Adverse Events, Serious Adverse Events and Death | Serious adverse events | 2 Participants |
| Olmesartan | Number of Participants With Adverse Events, Serious Adverse Events and Death | Deaths | 0 Participants |